跳至主要内容
临床试验/NCT05244915
NCT05244915终止不适用

Development and Feasibility of a Supportive Care Intervention for Older Caregivers of Older Adults with Advanced Cancer

University of Rochester1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2021年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
73
试验地点
1
主要终点
Time for caregivers to complete the GA

研究概览

简要总结

This project assesses the feasibility of utilizing the geriatric assessment as a tool to identify distressed older caregivers of older adults with cancer. The investigator will engage key stakeholders including older caregivers of older adults with cancer, experts in geriatric oncology and primary care physicians to develop and pilot a supportive care intervention to improve outcomes in older caregivers.

详细描述

Older caregivers of older adults with cancer (described here-on as "older caregivers") are at high risk for increased burden and negative physical and psychological outcomes. Despite this, identification of older caregivers at risk for burden remains a challenge and evaluation of supportive care interventions and guidelines for this population remains limited. Health outcomes of older adults with cancer and their caregivers are inter-related and it is important to evaluate and support the health of both. The geriatric assessment (GA) is a valuable tool to evaluate health and age-related conditions (e.g., physical and cognitive function) of older adults with cancer and guide supportive care. Identifying older adults with age-related conditions can help to identify caregivers who are at increased risk for the negative impacts of caregiving. This project seeks to gather preliminary data on the health of older caregivers and to develop and pilot high priority supportive care interventions for this population. The investigator will examine the feasibility of utilizing the GA as a tool to identify distressed older caregivers. The investigator will engage key stakeholders including, older caregivers and older adults with cancer, experts in geriatric oncology and primary care physicians to develop and pilot a supportive care intervention to improve outcomes in older caregivers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient Inclusion Criteria
  • •Patient and caregiver be aged 65 or older
  • •Patient with a diagnosis of solid tumor malignancy or lymphoma, any stage
  • •Patients who have initiated a new line of treatment (surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy) OR are being considered for new line of treatment (surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy).
  • •Patients and caregivers must be able to provide informed consent, or if it is determined that they do not have decision-making capacity, a patient-designated health care proxy must sign consent per institutional University of Rochester and Research Subject Review Board policies on consent for incapacitated/decisionally impaired subjects.

排除标准

  • •Patient or caregiver is less than 65 years of age
  • •Patient and caregivers who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy available to sign consent.
  • •Caregiver Inclusion Criteria
  • •Caregivers enrolled in phase I
  • •Patient and caregiver have completed a GA
  • •Caregiver Exclusion Criteria
  • •Patient and caregiver have not completed a GA
  • •Stakeholder Inclusion Criteria
  • •Member of SCOREboard Community Advisory Board
  • •Aged 65 years or older
  • •Has been a family member, partner, friend or caregiver to an older adult with cancer
  • •Stakeholder Exclusion Criteria • None
  • •Geriatric Oncology Expert Inclusion Criteria
  • •Members of the Cancer and Aging Research Group
  • •Primary care physicians who care for older adults
  • •Geriatric Oncology Expert Exclusion Criteria

研究组 & 干预措施

Experimental

Experimental

Participants will receive a geriatric assessment which consists of validated questionnaires that are used to assess health status of older adults with cancer. Based on participant responses, tailored recommendations will be provided.

干预措施: Experimental (Delphi Surveys) (Other)

Experimental

Experimental

Participants will receive a geriatric assessment which consists of validated questionnaires that are used to assess health status of older adults with cancer. Based on participant responses, tailored recommendations will be provided.

干预措施: Experimental (Focus Groups) (Other)

Experimental

Experimental

Participants will receive a geriatric assessment which consists of validated questionnaires that are used to assess health status of older adults with cancer. Based on participant responses, tailored recommendations will be provided.

干预措施: Qualitative interviews (Other)

结局指标

主要结局

Time for caregivers to complete the GA

时间窗: 8 weeks per patient

Time to complete the GA per caregiver will be determined by summing the time to complete self-administered and clinic portions of GA.

Percentage of participants who enroll and complete the GA

时间窗: 8 weeks per participant

Percentage of participants who were approached, enrolled in the study and completed the GA will be determined.

Caregiver satisfaction with completing the GA

时间窗: 8 weeks per patient

Caregivers will complete a questionnaire to assess satisfaction with completing the GA

次要结局

  • Percentage of caregiver supportive care recommendations that are implemented by patient/caregiver physicians(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sindhuja Kadambi

Senior Instructor - Department of Medicine , Hematology/Oncology (SMD)

University of Rochester

研究点 (1)

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